VIenna Pilot Study for Automated Annular Suturing Technology (VIP-RAM)

Medical University of Vienna

Status: Unknown

Conditions: Mitral Valve Disease; Aortic Valve Disease

Treatments: Procedure: automated annular suturing

Study type: Interventional

Funder types: Other

Identifiers

NCT04659655

EC 1660/2019

Details and patient eligibility

About

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

Full description

This study is a clinical, single-center pilot-study to evaluate safety and performance. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with low to moderate operative risk (Defined by STS mortality risk below 8%)
• Patients above the age of 18 years
• Patients willing and able to sign the informed consent

Exclusion criteria

• Patients with active endocarditis
• Patients with previous cardiac surgery other than pacemaker implantation
• Emergency procedures
• Patient who did not sign the informed consent form and/ or refuse to participate
• Patients unable to read or understand the informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

surgical aortic valve replacement

Other group

Description:

n=20 patients with aortic valve pathology and indication for surgical aortic valve replacement

Treatment:

Procedure: automated annular suturing

surgical mitral valve replacement

Other group

Description:

n=10 patients with mitral valve pathology and indication for surgical mitral valve replacement

Treatment:

Procedure: automated annular suturing